Hydromorphone Hydrochloride NDC 0409-2634

NDC codes

FDA NDC Directory

Product NDC (as listed)0409-2634Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00409-2634Add the package segment from the table below.

Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC	11-digit (billing)	Package
0409-2634-01	00409263401	10 VIAL, SINGLE-DOSE in 1 BOX (0409-2634-01) / 1 mL in 1 VIAL, SINGLE-DOSE (0409-2634-10)Marketed from Aug 8, 2008
0409-2634-05	00409263405	10 VIAL, SINGLE-DOSE in 1 BOX (0409-2634-05) / 5 mL in 1 VIAL, SINGLE-DOSE (0409-2634-25)Marketed from Aug 7, 2008
0409-2634-50	00409263450	1 VIAL, SINGLE-DOSE in 1 BOX (0409-2634-50) / 50 mL in 1 VIAL, SINGLE-DOSEMarketed from Jul 31, 2008

How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules

Product information

Brand name (proprietary): Hydromorphone Hydrochloride
Generic name (nonproprietary): hydromorphone hydrochloride
Active ingredients: Hydromorphone hydrochloride — 10 mg/mL
Dosage form: Injection, Solution
Route: Intramuscular, Intravenous, Subcutaneous
Labeler: Hospira, Inc.
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 078591
Marketing start: Jul 31, 2008
Listing expires: Dec 31, 2027
DEA schedule: CII
Other FDA classes: Full Opioid Agonists (Mechanism)
Identifiers: Product ID 0409-2634_50886ad5-eeca-4fe7-beb0-01305f92c65dSPL ID 50886ad5-eeca-4fe7-beb0-01305f92c65dSPL set ID 3832ede8-d3fc-455d-ecab-3b77be5869f5RxCUI 1724338, 1724340, 1724341UNII L960UP2KRW
Pharmacologic class: Opioid Agonist

Billing references

What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.

HCPCS codeNo match

No drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.

Administration

Drug administration (CPT 96360–96549)

When a clinician administers the drug, the administration is reported separately. Codes in this range cover hydration, therapeutic injections and infusions, and chemotherapy or other complex drug administration. The right code depends on route, duration and drug type, and self-administered drugs are not billed this way.

How CPT relates to drug billing

NDC on a medical claim

N400409263401 followed by a unit qualifier and the quantity

Package 00409-2634-01. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier

Product label

Current FDA label (SPL), effective Apr 21, 2026. This label includes a boxed warning.

Indications (excerpt from the label)

Hydromorphone Hydrochloride Injection [high potency formulation (HPF)] is indicated for use in opioid-tolerant patients who require higher doses of opioids for the management of pain severe enough to require an opioid analgesic and for which alternate treatments are inadequate. Patients considered opioid tolerant are those who are taking for one week or longer, around-the-clock medicine consisting of at least 60 mg oral morphine per day, or at least 25 mcg transdermal fentanyl per hour, or at least 30 mg oral oxycodone per day, or at least 8 g oral hydromorphone per day, or at least 25 mg oral oxymorphone per day, or at least 60 mg oral hydrocodone per day, or an equianalgesic dose of anothe…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 078591

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under ANDA 078591
Product	Strength	Form · route	Labeler	Product NDC
Hydromorphone Hydrochloride	Hydromorphone hydrochloride 10 mg/mL	Injection, SolutionIntramuscular, Intravenous, Subcutaneous	Teva Parenteral Medicines, Inc.	0703-0018
Hydromorphone Hydrochloride	Hydromorphone hydrochloride 10 mg/mL	Injection, SolutionIntramuscular, Intravenous, Subcutaneous	Teva Parenteral Medicines, Inc.	0703-0110
Hydromorphone Hydrochloride	Hydromorphone hydrochloride 10 mg/mL	Injection, SolutionIntramuscular, Intravenous, Subcutaneous	Teva Parenteral Medicines, Inc.	0703-0113